1. Field of the Inventions
The present inventions relate generally to handle apparatus for use with a steerable device for introducing diagnostic and therapeutic elements into the body.
2. Description of the Related Art
There are many instances where physicians must introduce diagnostic and therapeutic apparatus, such as diagnostic and therapeutic electrodes, ultrasound transducers, biopsy devices and other surgical tools, into the body. The diagnostic and therapeutic apparatus are often carried by catheters, which allow physicians to gain access to the body in a minimally invasive manner by way of bodily lumens. In cardiac treatment, for example, a catheter is advanced through a main vein or artery into the region of the heart that is to be treated.
One method of introducing diagnostic and therapeutic apparatuses into the body is to introduce a tubular member (typically a xe2x80x9csheathxe2x80x9d) into the vicinity of the targeted region. A diagnostic or therapeutic apparatus is then passed through the tubular member to the targeted region. If necessary, the diagnostic or therapeutic apparatus may be removed after its function is performed, but the tubular member left in place, so that other apparatus may be advanced to the targeted region to complete the diagnostic and/or therapeutic procedure.
Precise placement of the diagnostic or therapeutic apparatus is very important, especially in those procedures concerning the heart. To that end, some conventional sheaths are guided to the targeted region with a steerable catheter that is located within the sheath lumen. Once the sheath reaches the targeted region, the steerable catheter is removed from the sheath and a catheter carrying the diagnostic or therapeutic apparatus is advanced through the lumen. This type of sheath lacks any onboard steering mechanism. As a result, redeployment of the distal portion of the sheath, even to a region in close proximity to the initially targeted region, requires the withdrawal of the diagnostic or therapeutic apparatus and the reintroduction of the steering catheter.
Other conventional sheaths include a steering mechanism that allows the physician to deflect the distal portion of the sheath. The steering mechanism consists primarily of one or more steering wires. One end of each steering wire is secured to the distal end of the sheath, while the other end is secured to a steering control device, such as the rotating cam and steering control knob arrangement commonly found in steerable catheters. Rotation of the control knob causes one of the wires to impart a pulling force on the distal portion of the sheath, thereby causing the distal portion of the sheath to deflect. To promote steerability, the distal portion of the sheath (which is relatively short) is typically formed from relatively soft, flexible material. Conversely, the proximal portion (which is relatively long) is formed from relatively hard, less flexible material that provides better torque transmission properties.
The inventors herein have determined that there are a number of shortcomings associated with handles conventionally used with steerable sheaths. For example, some conventional handles include a luer fitting on the proximal end thereof and a rotatable steering device that is operably connected to a steering wire. A tubular device is connected to the luer fitting on the handle with a Toughy-Borst or other connector. Rotation of the steering device causes the portion of the handle with the luer fitting to move axially relative to the remainder of the handle. This can be problematic because the tubular device typically remains in place, thereby causing the handle (and the sheath connected to the handle) to move back and forth and/or rotate.
The inventors herein have also determined that some conventional handles tend to roll around on the patient when the steering knob is rotated. As such, these handles must be operated with both hands or fixedly secured to the patient.
Some conventional handles include a strain relief element that must be glued or otherwise attached to the handle. The inventors herein have determined that the design of conventional strain relief elements adds extra steps to the manufacturing process and, accordingly, increases the cost of the handle.
Accordingly, the general objective of the present invention is to provide an apparatus that avoids, for practical purposes, the aforementioned problems. In particular, one objective of the present invention is to provide a handle apparatus for use with a steerable device that does not suffer from some or all of the aforementioned problem associated with conventional handles.
In order to accomplish some of these and other objectives, a handle apparatus in accordance with one embodiment of a present invention includes handle body defining an inner chamber, a trolley member slidably located at least partially within the inner chamber, adapted to be connected to a steering wire and defining a trolley member lumen, and a steering member rotatably coupled to handle body and operably connected to the trolley member such that rotation of the steering member axially repositions the trolley member, the steering member including a steering member lumen substantially axially aligned with the trolley member lumen.
In order to accomplish some of these and other objectives, a handle apparatus in accordance with one embodiment of a present invention includes a handle body defining an outer surface, a steering member defining an inner surface, and a trolley member adapted to be connected to a steering wire and at least partially located between the handle body outer surface and the steering member inner surface. The trolley member is operably connected to the steering member such that the trolley member will be axially repositioned in response to rotation of the steering member about the handle body.
Such handle apparatus preferably include a fitting for a luer or other connector used to connect a tubular device to the handle apparatus and allow a catheter to pass therethrough. The trolley members in each apparatus move relative to the handle body and steering member to push or pull the steering wire distally or proximally. The handle body and steering member will not move longitudinally relative to one another when the steering member is rotated. As a result, handle body and sheath will not move longitudinally during steering operations as is the case with many conventional handles.
In order to accomplish some of these and other objectives, a handle apparatus in accordance with one embodiment of a present invention includes a handle body with at least one wing member. The wing member advantageously prevents the handle body from rotating or rolling relative to the patient.
In order to accomplish some of these and other objectives, a handle apparatus in accordance with one embodiment of a present invention includes a handle body and a strain relief including a plurality of spaced portions. Such a strain relief element may be integrally formed with the handle body, thereby eliminating some of the manufacturing steps and costs associated with conventional strain relief elements.
The above described and many other features and attendant advantages of the present inventions will become apparent as the inventions become better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings.